Carlos García Collado

Hospital Universitario Infanta Leonor

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Cristina Pérez-Ramírez

Hospital Universitario Virgen de las Nieves

R López-Sepúlveda

Instituto de Investigación Biosanitaria de Granada

Carolina Alarcón-Payer

Hospital Universitario Virgen de las Nieves

Manuel Romero‐Gómez

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas

MÁ

Miguel Ángel Calleja Hernández

Hospital Universitario Virgen Macarena

Benjamín Pardo-Yules

Hospital Universitario de Valme

N Martínez-Casanova

Hospital Clínico Universitario Virgen de la Victoria

Mohammed Eslam

Westmead Institute for Medical Research

Alberto Jiménez-Morales

Hospital Universitario Virgen de las Nieves

Ramón Morillo-Verdugo

Hospital Universitario de Valme

Cooperative Institutions

Columbus Oncology and Hematology Associates

129

University of Florida

127

Hospital Universitario Virgen de las Nieves

Universidad de Granada

Instituto de Investigación Biosanitaria de Granada

National Institutes of Health Clinical Center

Reckitt Benckiser (United States)

Complejo Hospitalario Universitario de Granada

Case Western Reserve University

Center for Drug Evaluation and Research

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CP-007 Hepatitis c virus treatment-related anaemia and its association with higher sustained virologic response rate

Clinical pharmacy (2015)

R López-Sepúlveda Carlos García Collado Jaileene Pérez‐Morales CM Valencia Soto FJ Orantes

Background

Some authors have described that among Hepatitis C Virus (HCV) genotype 1-infected patients treated with dual therapy, anaemia has been associated with higher rates of Sustained Virological Response (SVR) as well as the use of erythropoiesis-stimulating agents.

Purpose

To investigate the relationships between treatment outcomes, anaemia, and their management with ribavirin dose reduction and/or darbepoetin in patients treated with boceprevir (BOC) or telaprevir (TLV) in a tertiary hospital.

Material and methods

Observational study. Data was collected from pharmacotherapeutic records of patients who initiated therapy with TLV or BOC between December'12 and May'13. Anaemia was defined as haemoglobin (Hb) <10.5 mg/dL. Darbepoetin was permitted for anaemic patients after ribavirin dose reduction. The variables were: age, sex, reduction of ribavirin dose and use of darbepoetin.

Results

36 patients were studied (26 men and 10 women). 23 (63.8%) patients were treated with TLV and 13 (36.2%) with BOC. 25 (69.5%) patients reached SVR (16 (69.5%) for TLV and 9 (69.2%) for BOC). 12 of these patients experienced anaemia (48%) (7 (43.8%) for TLV and 5 (55.6%) for BOC). The total number of patients who experienced anaemia was 17 (47.2%) (9 (39.1%) for TLV and 8 (61.5%) for BOC), 16 patients (44.4%) had a reduction in their ribavirin dose (8 (34.8%) for TLV and 8 (61.5%) for BOC) and 12 patients (33.3%) used darbepoetin (6 (26.1%) for TLV and 6 (46.1%) for BOC); 8 of these 12 (66.6%) patients showed SVR, 1 relapsed and 3 abandoned treatment due to adverse events (4 (66.6%) for TLV and 4 (66.6%) for BOC).

Conclusion

Among our genotype 1-infected patients treated with BOC or TLV anaemia was not associated with higher rates of SVR. Patients with darbepoetin did not have higher rates of SVR. Percentages of SVR were similar between TLV and BOC.

References and/or acknowledgements

No conflict of interest.

Telaprevir

Boceprevir

Darbepoetin alfa

Hepatitis C

Pegylated interferon

10.1136/ejhpharm-2015-000639.7

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Different distribution of the common HFE variants between western and eastern Spanish populations evidences an independent haplotype gene flow

Revista del Laboratorio Clínico (2017)

Carolina Monzó Bárbara Ortiz Concepción Tomás Carlos García Collado C. González-Muñoz

Hereditary hemochromatosis

High Resolution Melt

10.1016/j.labcli.2016.12.003

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Citations (3)

CPC-140 Therapeutic Options in Anti-NMDA Receptor Encephalitis

European Journal of Hospital Pharmacy (2013)

Antonio Paredes R López Sepúlveda Carlos García Collado N Martínez Casanova E Puerta García

Background

Despite the expanding knowledge base, much remains to be understood about effective treatments to treat the many symptoms of anti-NMDA receptor encephalitis (anti-NMDA RE).

Purpose

To describe the treatment options for a case of refractory status epilepticus associated with non paraneoplastic anti-NMDA RE.

Materials and Methods

Revised drug-treatment history of the patient.

Results

A 22-year-old woman with a family history of epilepsy and an arteriovenous malformation (AVM) of the brain, presented a generalised tonic-clonic without clear focal onset and post-critical confusion. She was in non-convulsive status epilepticus. Treatment was initiated with various intravenous drugs during the 50 days of the status: diazepam, phenytoin, valproic acid, levetiracetam, clonazepam, midazolam, propofol, lacosamide, ketamine, and lidocaine. It was decided to proceed with induction of barbiturate coma three times, requiring supratherapeutic doses in the second one. Oxcarbazepine was administered via feeding tube. With these treatments, momentary remission status was achieved although epileptiform activity reappeared when the pharmacological effect expired. Thirty days after admission, it was decided to repeat computed tomography for development of AVM and investigate again whether the cerebrospinal fluid was positive for anti-NMDA. This being the case, teatment was initiated with methylprednisolone and immunoglobulins. She continued with clinical status, but electrical brain activity began to fade at the same time that the patient was starting to tolerate enteral nutrition and so oxcarbazepine possibly began to be absorbed. After discontinuing sedation the patient awoke and opened her eyes. Electroencephalogram was repeated and epileptiform activity had disappeared completely. Facial dyskinesias were treated with clonazepam.

Conclusions

Whereas the best treatment approach for anti-NMDA RE encompasses a combination of immunotherapy, intensive care, and rehabilitation, there is a dearth of information regarding management of psychiatric and behavioural symptoms [1]. The possibility of resolving the status by oxcarbazepine gavage opens a window into the use of drugs by this route in the event of failure of standard treatment.

Reference

Sansing LH, Tüzün E, Ko MW, Baccon J, Lynch DR, Dalmau J. A patient with encephalitis associated with NMDA receptor antibodies. Nat Clin Pract Neurol. 2007 May;3(5):291–6. No conflict of interest.

Levetiracetam

Oxcarbazepine

Anti-NMDA Receptor Encephalitis

Midazolam

10.1136/ejhpharm-2013-000276.597

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Issue Information

The Journal of Clinical Pharmacology (2019)

Jakub Wroński Piotr Fiedor Mark Farha Eric Masson Helen Tomkinson

Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacology (JCP) for original research, special reviews, commentaries, and case reports on all phases of drug development from absorption, disposition, metabolism, excretion interactions, and preferred uses through post-marketing evaluations.

10.1002/jcph.1407

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Oxcarbazepine via nasogastric tube in anti-nmda receptor autoimmune encephalitis

European journal of clinical pharmacy (2014)

Antonio Paredes Carlos García Collado CA Rodríguez N Martínez Casanova M F Martin

Objective: Describe treatment options for a case of refractory status epilepticus associated with non-paraneoplastic anti-NMDA receptor encephalitis. Case summary: A 22 year old woman presented a generalized tonic-clonic seizure without clear focal onset and post-critical confusion. She was in non-convulsive status epilepticus. Treatment was initiated with intravenous drugs during the 50 days of the status: diazepam, phenytoin, valproic acid, levetiracetam, clonazepam, midazolam,propofol, lacosamide, ketamine, lidocaine and induction of barbiturate coma three times. Oxcarbazepine was administered via feeding tube. Thirty days after admission, a further cerebrospinal fluid analysis was anti-NMDA antibody-positive. Treatment was initiated with methylprednisolone and immunoglobulins. She continued with clinical status, but electrical brain activity began to fade at the same time that the patient was starting to tolerate enteral nutrition and oxcarbazepine. Discussion: Treatment used in status epilepticus is usually by parenteral route.Feeding tube can also be used to administer drugs that cannot be given parenterally.Possibly the patient began to fade because oxcarbazepine began to be absorbed.Clinical guidelines do neither specifically recommend oxcarbazepine nor feeding tube drug administration for the treatment of status epilepticus. Conclusion: The possibility of resolving the status by oxcarbazepine gavage opens a window into the use of drugs by this route in the event of failure of Standard therapy

Oxcarbazepine

Levetiracetam

Clonazepam

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CP-006 Practical utility of itpa genotipation in a tertiary hospital

Clinical pharmacy (2015)

R López-Sepúlveda CM Valencia Soto Carlos García Collado Jaileene Pérez‐Morales FJ Orantes

Background

Inosine triphosphatase (ITPA) genotyping is used for predicting anaemia in patients with genotype 1 chronic hepatitis C. The AA and CA genotypes have the lowest incidence of anaemia.

Purpose

To compare the incidence of anaemia, the reduction in ribavirin (RBV) dose and the use of darbepoetin in patients treated with boceprevir or telaprevir before and after the introduction of ITPA genotyping in a tertiary care hospital.

Material and methods

Observational, pre-post intervention study using pharmacotherapeutic records of patients treated with telaprevir or boceprevir before and after the introduction of ITPA genotyping. Anaemia was defined as haemoglobin (Hb) <10.5 mg/dL. Baseline characteristics were age, sex, fibroscan, basal Hb, nadir Hb and ITPA genotype. Homogeneity of baseline characteristics was evaluated by the t-test. Comparisons of the incidence of anaemia, the reduction of RBV dose and the use of darbepoetin were made with the independent proportions test.

Results

Before genotyping 37 patients were included (27 male, 10 female): Mean fibroscan was 22 kpa, mean basal Hb was 15.6 mg/dL and mean nadir Hb was 10.4 mg/dL. After genotyping 20 patients were included (16 male, 4 female): 18 patients were CC (90%) and two were AC (10%). Mean fibroscan was 11.9 kpa (significantly lower than before genotyping). Mean basal Hb was 16.1 mg/dL and mean nadir Hb was 10.9 mg/dL. Comparison of before and after results. Reduction in RBV dose: 43.2% vs. 40% (p = n.s.); anaemia: 35.1% vs. 45% (p = n.s.); and treatment with darbepoetin: 32.4% vs. 25% (p = n.s.)

Conclusion

Although the reduced use of darbepoetin suggests the practical utility of this resource, a higher percentage of patients experienced anaemia after ITPA genotyping was available. This is possibly because the RBV dose was reduced by less than before genotyping even though 90% of patients were the CC (pro-anaemia) genotype. Greater emphasis should be placed on this resource. No conflict of interest.

ITPA

Telaprevir

Boceprevir

10.1136/ejhpharm-2015-000639.6

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Thalidomide with peginterferon alfa-2b and ribavirin in the treatment of non-responders genotype 1 chronic hepatitis C patients: proof of concept Talidomida, peginterferón alfa-2b y ribavirina en el tratamiento de pacientes no respondedores con hepatitis crónica C genotipo 1: estudio piloto

Benjamín Pardo-Yules Rocío Gallego‐Durán Mohammed Eslam Carlos García Collado Lourdes Grande

Peginterferon alfa-2a

Hepatitis C

Sofosbuvir

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4CPS-194 Clinical impact of genomic biomarkers predictors of response and the therapeutic strategy in patients with myelodysplastic syndrome associated with del(5q)

Section 4: Clinical pharmacy services (2019)

Carolina Alarcón-Payer A Jiménez Morales Carlos García Collado F. Hernández Mohedo Manuel Jurado Chacón

Background

According to OMS-2016, myelodysplastic syndrome (MDS) associated with del(5q) is manifested by a transfusion-dependent progressive bone marrow failure, with Lenalidomide acting as the intended drug to treat this syndrome.

Purpose

To analyse the clinical impact of the directed risk-stratification therapy and to evaluate the clinical benefit associated with the discontinuation of the Lenalidomide treatment due to side effects or intolerance.

Material and methods

Three-year prospective observational study on 69 cases of MDS in a third-level hospital, 17 of them with del(5q). Mutational profile analysis using a Next Generation Sequencing (NGS) on a panel of 28 genes mutated in haematologic malignancies prior to Lenalidomide treatment decision-making, with TP53 mutation as ultra-high-risk profile for discouraging its use. Variables considered: beginning of treatment, Lenalidomide mean dose, ending of treatment and beginning of discontinuation, side effects, time after discontinuation, evaluation of the drug withdrawal response and cost savings.

Results

Sixty-nine MDS cases were analysed by NGS. Mutational risk profile: high (six), low (21), intermediate (18), very high (seven) and very low (17). Seventeen cases were detected as MDS associated with del(5q) and five of them showed positive TP53 mutation and were treated with hypomethylating agents instead of Lenalidomide. Seven of them showed DNMT3A, ASXL1, SF3B1 and TET2 mutations. Eleven patients were treated with Lenalidomide, the treatment was discontinued in six of them due to side effects and the dose reduced in three cases due to intolerance. Reported side effects: Grade 4 neutropaenia, rhabdomyolysis, erythematous reactions and haemolytic crisis. All patients in which Lenalidomide was discontinued, maintained complete haematological and cytogenetic response, reaching a mean monitoring time of 12 months since the withdrawal of Lenalidomide. The cost saving associated with the discontinuation of Lenalidomide 10 mg was €48 000 per patient per year.

Conclusion

The use of NGS permits the selection of the mutational profile of each patient, resulting in a change in therapeutic decision-making, the selection of more cost-effective drugs and a directed and personalised treatment. Discontinuation of Lenalidomide, due to side effects or intolerance, involves a clinical benefit to those patients who maintain a complete haematological response after interruption of the treatment.

Reference and/or acknowledgements

Chesnais, et al. Blood 2016;127:749–60. No conflict of interest.

Discontinuation

10.1136/ejhpharm-2019-eahpconf.343

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[Boceprevir and telaprevir safety in routine clinical practice].

PubMed (2014)

R López-Sepúlveda Cristina Fernández‐López Carlos García Collado A Jiménez Morales C Valencia Soto

Dysgeusia

Leukopenia

10.7399/fh.2014.38.1.1142

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Citations (2)

Pomalidomide in the treatment of multiple myeloma: design, development and place in therapy

Drug Design Development and Therapy (2017)

Rafael Ríos Martin-Garcia Agustin Carolina Alarcón-Payer Sánchez-Rodríguez Dolores Valle Díaz de la Guardia Ana María

Abstract: Multiple myeloma is a very heterogeneous disease with variable survival. Despite recent progress and the widespread use of new agents, patients with relapsed and refractory disease have a poor outcome. Immunomodulatory drugs play a key role in both the front-line and the relapsed/refractory setting. The combination of pomalidomide (POM) and dexamethasone is safe and effective in relapsed and refractory patients, even in those with high-risk cytogenetic features. Furthermore, it can be used in most patients without the need to adjust according to the degree of renal failure. In order to further improve the results, POM-based triplet therapies are currently used. This article highlights the most relevant issues of POM and POM-based combinations in the relapsed/refractory multiple myeloma setting, from a pharmacological and clinical point of view. Keywords: multiple myeloma, pomalidomide, triplet therapy, dexamethasone

Pomalidomide

Refractory (planetary science)

10.2147/dddt.s115456

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Citations (39)